Steris Warned After Reports of Flames and Sparks From Cleaning Units
Steris Corporation’s Amsco Sonic Energy Cleaners are misbranded after an inspection revealed user complaints of product-related fires, the FDA said in a warning letter. For example, one complaint said a user “smelled a strong burning odor and observed flames shooting out the back of the unit,” according to the letter, posted last week to the agency’s website.
The letter documented several other complaints, including:
- “Visible flame coming from the right side of the unit;”
- Interior wires melted and caught on fire;
- A unit was sparking and smoking, smelling like something had burned;
- A switch was smoking and burning. “Can see flames, but can’t get to plug to unplug it;”
- “Sonic Cleaner caught fire. No injuries and was under control before the fire department arrived;”
- A unit caught on fire and a building was evacuated. This was the second unit to catch on fire within a year;
- A unit caught fire and was damaged beyond repair; and
- A unit caught fire while not in use.
Steris could not be reached for comment by press time.
The letter can be viewed at www.fda.gov/foi/warning_letters/s6461c.pdf.